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510(k) Data Aggregation

    K Number
    K120785
    Device Name
    OMNI 3 OXYGEN SYSTEM
    Manufacturer
    CAIRE, INC.
    Date Cleared
    2012-10-25

    (224 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAIRE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The eQuinox Oxygen System is intended for the administration of supplemental oxygen. The eQuinox Oxygen System is prescription legend required.
    Device Description
    The eQuinox Oxygen System is an oxygen concentrator that provides continuous flow or in pulse mode, an oxygen bolus. The eQuinox Oxygen System is based on pressure swing adsorption (PSA) principles. The eQuinox Oxygen System operates from AC power, or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in pulse flow mode. During pulse flow mode, oxygen is delivered to the patient through a pulse flow valve when the start of inhalation is detected. The eQuinox Oxygen System consists of pneumatic and electrical components, AC power supply, DC cable and lithium ion batteries. The system has inlet filtration, air compressor, and Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.
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    K Number
    K080023
    Device Name
    MODIFICATION TO: SPIRIT
    Manufacturer
    CAIRE, INC.
    Date Cleared
    2008-06-16

    (164 days)

    Product Code
    BYJ, CFR
    Regulation Number
    868.5655
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAIRE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device (digital oxygen conserving device-DOCD). The Spirit 300 is neither a life sustaining nor life supporting device.
    Device Description
    The spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure relief valves, a manifold, an electronic printed circuit board conserving device (digital) and a protective case. The dewar has a capacity and capability to store 0.3L of liquid oxygen. The economizer regulator either draws gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below the 20 PSI, the economizer regulator will draw liquid oxygen, from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar headspace to be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold, dependent on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or diverts a 2L PM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosage just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.
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    K Number
    K050153
    Device Name
    SPIRIT, MODEL HAS
    Manufacturer
    CAIRE, INC.
    Date Cleared
    2005-04-15

    (81 days)

    Product Code
    BYJ, SPI
    Regulation Number
    868.5655
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAIRE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirit 300 HAS will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing 93% liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 HAS is intended to be transfilled only by the In-X Corporation's Home-Away System. The Spirit 300 HAS is neither a life sustaining nor life supporting device.
    Device Description
    The Spirit 300 HAS is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. Dependant on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent setting for 1, 1.5, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting. The Spirit 300 HAS is filled from a concentrator liquefaction device.
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    K Number
    K013251
    Device Name
    SPIRIT 300
    Manufacturer
    CAIRE, INC.
    Date Cleared
    2001-12-18

    (81 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAIRE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAIRE Spirit 300 will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 is neither a life sustaining nor life supporting device.
    Device Description
    The Spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuuminsulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. The economizer regulator riams the ony gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below 20 PSI, the economizer regulator will draw liquid oxygen from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar head regulator be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold. Dependant on the flow selection setting, the manifold either delivers the gas to the the manifolial Deportually diverts a 2 LPM continuos flow directly to the oxygen outlet. The continuos flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.
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